Young people's views about the purpose and composition of research ethics committees:findings from the PEARL qualitative study

BACKGROUND: Avon Longitudinal Study of Parents and Children (ALSPAC) is a birth cohort study within which the Project to Enhance ALSPAC through Record Linkage (PEARL) was established to enrich the ALSPAC resource through linkage between ALSPAC participants and routine sources of health and social data. PEARL incorporated qualitative research to seek the views of young people about data linkage, including their opinions about appropriate safeguards and research governance. In this paper we focus on views expressed about the purpose and composition of research ethics committees. METHODS: Digitally recorded interviews were conducted with 48 participants aged 17–19 years. Participants were asked about whether medical research should be monitored and controlled, their knowledge of research ethics committees, who should sit on these committees and what their role should be. Interview recordings were fully transcribed and anonymised. Thematic analysis was undertaken, assisted by the Framework approach to data management. RESULTS: The majority of interviewees had little or no specific knowledge of ethics committees. Once given basic information about research ethics committees, only three respondents suggested there was no need for such bodies to scrutinise research. The key tasks of ethics committees were identified as monitoring the research process and protecting research participants. The difficulty of balancing the potential to inhibit research against the need to protect research participants was acknowledged. The importance of relevant research and professional expertise was identified but it was also considered important to represent wider public opinion, and to counter the bias potentially associated with self-selection possibly through a selection process similar to ‘jury duty’. CONCLUSIONS: There is a need for more education and public awareness about the role and composition of research ethics committees. Despite an initial lack of knowledge, interviewees were able to contribute their ideas and balance the rights of individuals with the wider benefits from research. The suggestion that public opinion should be represented through random selection similar to jury duty may be worth pursuing in the light of the need to ensure diversity of opinion and establish trust amongst the general public about the use of ‘big data’ for the wider public good

Who, What, Where: an analysis of private sector family planning provision in 57 low- and middle-income countries.

OBJECTIVE: Family planning service delivery has been neglected; rigorous analyses of the patterns of contraceptive provision are needed to inform strategies to address this neglect. METHODS: We used 57 nationally representative Demographic and Health Surveys in low- and middle-income countries (2000-2013) in four geographic regions to estimate need for contraceptive services, and examined the sector of provision, by women's socio-economic position. We also assessed method mix and whether women were informed of side effects. RESULTS: Modern contraceptive use among women in need was lowest in sub-Saharan Africa (39%), with other regions ranging from 64% to 72%. The private sector share of the family planning market was 37-39% of users across the regions and 37% overall (median across countries: 41%). Private sector users accessed medical providers (range across regions: 30-60%, overall mean: 54% and median across countries 23%), specialised drug sellers (range across regions: 31-52%, overall mean: 36% and median across countries: 43%) and retailers (range across regions: 3-14%, overall mean: 6% and median across countries: 6%). Private retailers played a more important role in sub-Saharan Africa (14%) than in other regions (3-5%). NGOs and FBOs served a small percentage. Privileged women (richest wealth quintile, urban residents or secondary-/tertiary-level education) used private sector services more than the less privileged. Contraceptive method types with higher requirements (medical skills) for provision were less likely to be acquired from the private sector, while short-acting methods/injectables were more likely. The percentages of women informed of side effects varied by method and provider subtype, but within subtypes were higher among public than private medical providers for four of five methods assessed. CONCLUSION: Given the importance of private sector providers, we need to understand why women choose their services, what quality services the private sector provides, and how it can be improved. However, when prioritising one of the two sectors (public vs. private), it is critical to consider the potential impact on contraceptive prevalence and equity of met need

Recognising the importance of 'family time-out' in consultations: An exploratory qualitative study

Objectives: Patients are often accompanied by family or companions during consultations, but little is known about how this might influence the process. We explored how the presence of a companion in a consultation contributes to communication and the decision-making process. Design: Observational study. Setting: A teaching hospital and a district general hospital in south-west England. Participants: 31 patients and their physicians were observed during consultations in which decisions to undergo palliative chemotherapy were made. Each patient was accompanied by at least one companion. Outcome measures: Communication patterns between physicians, patients and companions. Results: In addition to standard patient/physician interactions, patients and companions were often found to discuss medical information and exchange opinions between themselves without the physician actively participating. We called these instances 'family timeout'. On the occasion of disagreement between patients and companions about preferred treatment options, physicians and patients were able to agree the decision while acknowledging the differences in opinion. Conclusions: Instances of 'family time-out' may contribute to better consultation outcomes because they are understood and supported by the patient's social system. This study highlights the potentially important role of exchanges between patients and companions during consultations and how physicians may benefit from observation of such exchanges. We recommend testing the value of making space for family time-out during consultations. Also, we recommend further study into the medical ethics of family time-out. While the focus here is on palliative chemotherapy, this finding has implications for other consultations, particularly those involving difficult treatment decisions

Maintaining image quality for paediatric chest CTs while lowering dose: FBP versus SAFIRE

Objectives: Children have a greater risk from radiation, per unit dose, due to increased radiosensitivity and longer life expectancies. It is of paramount importance to reduce the radiation dose received by children. This research concerns chest CT examinations on paediatric patients. The purpose of this study was to compare the image quality and the dose received from imaging with images reconstructed with filtered back projection (FBP) and five strengths of Sinogram-Affirmed Iterative Reconstruction (SAFIRE). Methods: Using a multi-slice CT scanner, six series of images were taken of a paediatric phantom. Two kVp values (80 and 110), 3 mAs values (25, 50 and 100) and 2 slice thicknesses (1 mm and 3 mm) were used. All images were reconstructed with FBP and five strengths of SAFIRE. Ten observers evaluated visual image quality. Dose was measured using CT-Expo. Results: FBP required a higher dose than all SAFIRE strengths to obtain the same image quality for sharpness and noise. For sharpness and contrast image quality ratings of 4, FBP required doses of 6.4 and 6.8 mSv respectively. SAFIRE 5 required doses of 3.4 and 4.3 mSv respectively. Clinical acceptance rate was improved by the higher voltage (110 kV) for all images in comparison to 80 kV, which required a higher dose for acceptable image quality. 3 mm images were typically better quality than 1 mm images. Conclusion: SAFIRE 5 was optimal for dose reduction and image quality

An evaluation of SAFIRE’s potential to reduce the dose received by paediatric patients undergoing CT: a narrative review

Introduction: The purpose of this review is to gather and analyse current research publications to evaluate Sinogram-Affirmed Iterative Reconstruction (SAFIRE). The aim of this review is to investigate whether this algorithm is capable of reducing the dose delivered during CT imaging while maintaining image quality. Recent research shows that children have a greater risk per unit dose due to increased radiosensitivity and longer life expectancies, which means it is particularly important to reduce the radiation dose received by children. Discussion: Recent publications suggest that SAFIRE is capable of reducing image noise in CT images, thereby enabling the potential to reduce dose. Some publications suggest a decrease in dose, by up to 64% compared to filtered back projection, can be accomplished without a change in image quality. However, literature suggests that using a higher SAFIRE strength may alter the image texture, creating an overly ‘smoothed’ image that lacks contrast. Some literature reports SAFIRE gives decreased low contrast detectability as well as spatial resolution. Publications tend to agree that SAFIRE strength three is optimal for an acceptable level of visual image quality, but more research is required. The importance of creating a balance between dose reduction and image quality is stressed. In this literature review most of the publications were completed using adults or phantoms, and a distinct lack of literature for paediatric patients is noted. Conclusion: It is necessary to find an optimal way to balance dose reduction and image quality. More research relating to SAFIRE and paediatric patients is required to fully investigate dose reduction potential in this population, for a range of different SAFIRE strengths

Young people's views about consenting to data linkage:findings from the PEARL qualitative study

Abstract Background Electronic administrative data exist in several domains which, if linked, are potentially useful for research. However, benefits from data linkage should be considered alongside risks such as the threat to privacy. Avon Longitudinal Study of Parents and Children (ALSPAC) is a birth cohort study. The Project to Enhance ALSPAC through Record Linkage (PEARL) was established to enrich the ALSPAC resource through linkage between ALSPAC participants and routine sources of health and social data. Qualitative research was incorporated in the PEARL study to examine participants’ views about data linkage and inform approaches to information sharing. This paper focusses on issues of consent. Methods Digitally recorded interviews were conducted with 55 participants aged 17–19 years. Terms and processes relating to consent, anonymization and data linkage were explained to interviewees. Scenarios were used to prompt consideration of linking different sources of data, and whether consent should be requested. Interview recordings were fully transcribed. Thematic analysis was undertaken using the Framework approach. Results Participant views on data linkage appeared to be most influenced by: considerations around the social sensitivity of the research question, and; the possibility of tangible health benefits in the public interest. Some participants appeared unsure about the effectiveness of anonymization, or did not always view effective anonymization as making consent unnecessary. This was related to notions of ownership of personal information and etiquette around asking permission for secondary use. Despite different consent procedures being explained, participants tended to equate consent with ‘opt-in’ consent through which participants are ‘asked’ if their data can be used for a specific study. Participants raising similar concerns came to differing conclusions about whether consent was needed. Views changed when presented with different scenarios, and were sometimes inconsistent. Conclusions Findings from this study question the validity of ‘informed consent’ as a cornerstone of good governance, and the extent to which potential research participants understand different types of consent and what they are consenting, or not consenting, to. Pragmatic, imaginative and flexible approaches are needed if research using data linkage is to successfully realise its potential for public good without undermining public trust in the research process

Study protocol:the effectiveness and cost effectiveness of an employer-led intervention to increase walking during the daily commute: the Travel to Work randomised controlled trial

BACKGROUND: Physical inactivity increases the risk of many chronic diseases including coronary heart disease, type 2 diabetes and some cancers. It is recommended that adults should undertake at least 150 minutes of moderate intensity physical activity throughout the week but many adults do not achieve this. An opportunity for working adults to accumulate the recommended activity levels is through the daily commute. METHODS: Employees will be recruited from workplaces in south-west England and south Wales. In the intervention arm, workplace Walk-to-Work promoters will be recruited and trained. Participating employees will receive Walk-to-Work materials and support will be provided through four contacts from the promoters over 10 weeks. Workplaces in the control arm will continue with their usual practice. The intervention will be evaluated by a cluster randomized controlled trial including economic and process evaluations. The primary outcome is daily minutes of moderate to vigorous physical activity (MVPA). Secondary outcomes are: overall physical activity; sedentary time; modal shift away from private car use during the commute; and physical activity/MVPA during the commute. Accelerometers, GPS receivers and travel diaries will be used at baseline and one year follow-up. Questionnaires will be used at baseline, immediately post intervention, and one year follow-up. The process evaluation will examine the context, delivery and response to the intervention from the perspectives of employers, Walk-to-Work promoters and employees using questionnaires, descriptive statistics, fieldnotes and interviews. A cost-consequence study will include employer, employee and health service costs and outcomes. Time and consumables used in implementing the intervention will be measured. Journey time, household commuting costs and expenses will be recorded using travel diaries to estimate costs to employees. Presenteeism, absenteeism, employee wellbeing and health service use will be recorded. DISCUSSION: Compared with other forms of physical activity, walking is a popular, familiar and convenient, and the main option for increasing physical activity in sedentary populations. To our knowledge, this is the first full-scale randomised controlled trial to objectively measure (using accelerometers and GPS receivers) the effectiveness of a workplace intervention to promote walking during the commute to and from work. TRIAL REGISTRATION: ISRCTN15009100 (10 December 2014)

Risk Of Hypoglycemia Among T1dm Individuals Who Exercise Regularly

ABSTRACT Objective: Exercise training and sport activity are important for good health among those with type 1 diabetes mellitus (T1DM); however, fear of hypoglycemia is a clear barrier to participation. We examined both the main demographic and exercise training risk profiles for exercise-associated and nocturnal hypoglycemia, including indicators of unawareness. Mode of insulin delivery, whether multiple daily injections (MDI) via pen or continuous subcutaneous insulin infusion (CSII) via pump, was an important consideration. Research Design: Our study was based on data from an internet-based survey in the Netherlands that attracted T1DM participants who engage in routine exercise or sport activity. Results: The majority of survey participants reported experiencing hypoglycemia either sometimes (67.9%) or regularly (18.5%) during or after exercise, while 74% reported experience of nocturnal hypoglycemia. In contrast, only a very small number of survey participants reported complete unawareness surrounding symptom severity (\u3c 4%). Overall, regular exercise-associated hypoglycemia predicted the report of nocturnal hypoglycemia (OR= 14.44; P \u3c 0.001). Significant demographic predictors specific for exercise-associated hypoglycemia were sex, age, and number of years of exercise with T1DM (P \u3c0.05). Nocturnal hypoglycemia was influenced by duration of diagnosis and daily basal insulin dose requirements (P \u3c 0.05). Mode of insulin delivery (pen/pump) significantly influenced both exercise-associated (P= 0.002) and nocturnal (P= 0.042) hypoglycemic outcomes, depending on exercise type (endurance/non-endurance). Specifically, pump use, in the context of non-endurance exercise, was associated with high risk for both forms of hypoglycemia. Conclusions: While hypoglycemia is prevalent in individuals with T1DM who exercise regularly, hypoglycemia unawareness is not. Given that baseline insulin requirements were broadly tied to the above risk profiles, we conclude that exercise regimens to improve overall insulin sensitivity may be crucial to mitigating risk for hypoglycemic outcomes

Improving mechanical and neuromuscular deficits following anterior cruciate ligament reconstruction

Despite consistent resolution of knee laxity and return to physical activity following ACL reconstruction, a growing body of evidence implicates impaired weight acceptance strategies as frequent primary drivers in a host of poor long-term outcomes. Most egregiously, the majority of the people with ACL reconstruction will show radiographic evidence of knee osteoarthritis within 15 years of surgery. Abnormal compression of the knee joint due to impaired knee flexion during weight acceptance is exacerbated by a tendency toward concomitant co-contraction of the knee musculature. Despite a plethora of proposed training paradigms, performance deficits after ACL reconstruction prove particularly resistant to enduring change. The studies included in this dissertation examine the mechanical and neuromuscular impairments in weight acceptance during landing from a jump that underlie the limitations to success following ACL reconstruction. A path toward improving functional recovery by treating impairments in landing is suggested and a novel training approach is tested. First, a cross-sectional study examines both the impaired patterns of neuromuscular recruitment in people who have returned to sporting activity following ACL reconstruction and their relationship to mechanics in landing. A pre-test/post-test laboratory study further examines the relationship between imposed changes in landing mechanics and co-contraction between the hamstrings and the quadriceps musculature. Clarification of neuromuscular activation and coordination impairments allows development of specific treatment techniques. To address limitations in current practice, a new device, the Bodyweight Reduction Instrument to Deliver Graded Exercise (BRIDGE), is validated in a third study, in which the effects of body weight support on the mechanics of repetitive single leg hopping are tested. The use of the BRIDGE is then described in a clinical case study. Finally, a randomized clinical trial determines whether high volume jump training with reduced loading intensity via body weight support will preferentially enhance motor learning for improved coordination of the neuromuscular system during high demand tasks such as single leg landing. This dissertation thereby advances the science of rehabilitation to more effectively target mechanical and neuromuscular impairments that devastatingly contribute to the risk of re-injury and early onset osteoarthritis following ACL reconstruction